II. Factual Grounds

Manufacturers and their collaborators (including but not limited to clinics, refractive surgeons, and agents) withheld and distorted safety and effectiveness data (Section A) submitted to the Food and Drug Administration (FDA) so that LASIK devices would appear to have:

  • A FDA–acceptable adverse event rate of ≤1%, rather than the true rate of at least 20%
  • Only temporary adverse effects when, in fact, some persist for 6 months to many years
  • >90% effectiveness when the true rate is approximately 57% [cit6]

Starting during my tenure, FDA decision–making on LASIK devices was dominated by LASIK surgeons working hand–in–glove with LASIK manufacturers. Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of LASIK devices were the device manufacturers and its collaborators. Surgeons used LASIK devices in violation of required manufacturing quality controls (21 CFR 820), patient protections (including but not limited to 21 CFR 50; 54; 56; and 812), and reports of adverse events (including but not limited to 21 CFR 803; 812; and 820) when they manufactured and distributed LASIK devices in interstate commerce within the United State as:

  • Homemade lasers (“black boxes”)
  • Imported investigational lasers (“grey boxes”)
  • Illegal key cards (“Bermuda cards”) and
  • “Off–label” photorefractive keratectomy (PRK) lasers

As a consequence the FDA was deprived of knowledge of the full extent of LASIK injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devices under 21 CFR 812 and 21 CFR 814. In addition, LASIK manufacturers and their collaborators withheld safety and effectiveness information from their investigational device exemption (IDE) reports to the FDA. In addition, they hid LASIK injuries from FDA within the context of out–of–court settlement of innumerable lawsuits. Clinic–sponsored IDE studies cherry–picked, withheld, and hid data from FDA that clearly showed LASIK with excessive adverse event rates (greater than 1%). These activities were an industry–wide effort, organized wholly or in part by the manufacturers and their collaborators in order to circumvent FDA law and regulation. I will submit CONFIDENTIAL information on these matters separately to FDA’s Office of Criminal Investigation.

Published scientific data shows LASIK devices induce an average adverse event rate of about 22% that persists beyond six months to five or more years. Moreover, the published data (Section B) shows that LASIK devices transform healthy corneas into sick corneas that:

  • Never completely heal
  • Are permanently weakened, vulnerable to trauma and inflammation
  • Cause neuropathic dry eyes
  • Have pathology that progresses annually
  • Are vulnerable to blinding corneal bulging (keratectasia)
  • Compromises night vision
  • Have unstable vision corrections that regress
  • Require eye care that otherwise would not be needed

A. PMA Applicants Withheld and Distorted Safety Data In Submissions to FDA

Figure 1 is a LASIK industry graph [1] falsely showing that dry eyes, night vision, glare, and halos do not occur six months after LASIK. FDA reproduces the manufacturer’s graph on its website without attribution or identification of the evidence upon which it is based [2]. Visitors to the LASIK manufacturer’s website [3] are sent to FDA’s LASIK website to view the graph as if it was FDA’s. Manufacturers knew (and know) that these adverse events occur with a frequency much higher than 1% at 6 months post–LASIK.

Figure 1 is an example of untruthful and inaccurate information submitted to the FDA by manufacturers and their collaborators in support of premarket applications (PMA) for LASIK devices (P970005, P990010, P970053, P970043, P900016, P980008, P930016, P020050, P030008, P930008, P060004). These manufacturers and their collaborators have been engaged in, and still are engaged in, a pattern of falsifying, misrepresenting, manipulating, and withholding safety and effectiveness data from FDA to make their LASIK devices appear safer than they are.

LASIK Industry Graph Showing False Data

Figure 1. LASIK Industry Graph Showing False Data. From: http://www.agingeye.net/lasik/lasik.php

1. Falsified and Misrepresented Data in Submissions to FDA

LASIK manufacturers and their collaborators made and are making false statements to FDA when they report and label their devices with an adverse event rate of less than 1%. Figures 2–7 show that the manufacturers knew (know) that the adverse event rates are much higher than 5% and persist for at least 12 months. The vertical axis on each of these figures is percent post–LASIK vision changes compared to pre–operative values. The horizontal axis on each figure is the follow–up (FU) month post–LASIK at which data was collected. These data are taken from manufacturers documents submitted to FDA and identified in Table 1 [cit7].

LASIK Induced Adverse Events

Figure 2 – LASIK Induced Adverse Events.

The vertical axis is percent post–LASIK vision changes compared to pre–operative values. The horizontal axis is the follow–up (FU) month post–LASIK at which data was collected.
LASIK Induced Adverse Events

Figure 3 – LASIK Induced Adverse Events

The vertical axis is percent post–LASIK vision changes compared to pre–operative values. The horizontal axis is the follow–up (FU) month post–LASIK at which data was collected
LASIK Induced Adverse Events

Figure 4 – LASIK Induced Adverse Events

The vertical axis is percent post–LASIK vision changes compared to pre–operative values. The horizontal axis is the follow–up (FU) month post– LASIK at which data was collected.
LASIK Induced Adverse Events

Figure 5 – LASIK Induced Adverse Events

The vertical axis is percent post–LASIK vision changes compared to pre–operative values. The horizontal axis is the follow–up (FU) month post– LASIK at which data was collected.
LASIK Induced Adverse Events

Figure 6 – LASIK Induced Adverse Events

The vertical axis is percent post–LASIK vision changes compared to pre–operative values. The horizontal axis is the follow–up (FU) month post– LASIK at which data was collected.
LASIK Induced Adverse Events

Figure 7 – LASIK Induced Adverse Events

The vertical axis is percent post–LASIK vision changes compared to pre–operative values. The horizontal axis is the follow–up (FU) month post– LASIK at which data was collected.

The data shown in Figure 2–7 clearly show substantial adverse effects beyond six months post–LASIK. The following section shows that manufacturers and their collaborators pressured FDA to not count these adverse effects in the “adverse event rate”.

2. Manufacturers Pressured FDA to Not Count Certain Adverse Events.

FDA originally counted glare, halos, dry eye, night driving difficulties, and similar problems after excimer laser refractive surgery as adverse events, e.g. page 16 of the Patient Information Brochure for P970053c says “…adverse events beyond the first few months: night vision difficulty (48.1% at six months)…glare (34.4% at 6 months)…” LASIK manufacturers and their collaborators successfully pressured FDA to classify these problems as mere “symptoms” so that manufacturers could claim that the adverse event rate is less than one percent. FDA required an adverse event rate of less than one percent of eyes [4]. In 2009 FDA publicly acknowledged that “…halos, glare, night vision problems, and dry eye from LASIK should be reported to FDA..,” [5], in other words that these problems are “reportable events” and thus adverse unless proven unrelated to LASIK. The result is that the true adverse event for LASIK devices is much higher than 1% [cit8].

In addition to falsifying and misrepresenting these adverse events the manufacturers and their collaborators withheld significant adverse event data from FDA.

3. Manufacturers Withheld Safety Data

Table 1 shows that LASIK manufacturers withheld an average of about 30% of the follow–up data on adverse events, including but not limited to dry eyes, night vision problems, glare, and halos (see Table 1A in the Appendix for sources of the data). Manufacturers asserted that the missing data was not submitted because vision outcomes were so good that subjects would not come back for post–operative visits [6]. They repeatedly made this claim in meetings with FDA.

Table 1 – Percent Adverse Events Data Withheld by Manufacturers
ManufacturerFollow-Up (months)% Data Withheld
Kremer LASIK 12 79.9
Kremer LASIK 12 39.7
VISX LASIK 3 62.1
Nidek EC–5000 12 41.5
LADARVision 6 57.9
VISX Star S2, S3 6 29.4
LaserSight 6 88.2
LaserSight 6 73
VISX 6 4.3
LADARVision 4000 6 68.1
VISX Star S4 6 22.3
Allegretto Wave 3 7.6
Allegretto Wave 6 10.3
LADARVision 4000 3 29.9
VISX Star S4 6 1.1
VISX WaveScan 6 7
VISX Star S4 6 41.8
Allegretto Wave 6 12.3
LADARVision 4000 6 20.2
LADARVision 4000 & 600 60
Allegretto Wave3 4.2
Allegretto Wave36.4
MEL–80 62.2
Nidek EC–5000 12 5.2
VISX Star Wave 12 9.4
Sum = 724
N = 25
Mean = 29.7

Manufacturers and their collaborators withheld more than 10% of the adverse event data from 13 of the 25 studies, more than 20% from 12 studies, and more than 40% from seven studies. In addition, they withheld information from FDA about LASIK injuries that resulted in lawsuits and out–of–court

settlement that occurred during investigational studies and during FDA review of the PMAs. Manufacturers and their collaborators did not report these adverse events to FDA during my tenure at FDA [7].

The “true” adverse event rate is more than 1% at 6 months post–LASIK (Figures 2–7) [cit9]. For example, the manufacturers reported to FDA that dry eyes occur at ~21% (Figure 7, Table 3A), night vision problems at ~11% (Figure 6, Table 3A), glare at ~12% (Figure 6, Table 3A), and halos at ~14% (Figure 7). However, the published literature shows that these four adverse event rates are approximately 22%, 16%, 20%, and 19% respectively (Table 2). Thus the “true” adverse event rate six months or more post–LASIK is at least 20 times the FDA approvable rate of 1%.

Table 2. Adverse Event (AE) Rates at >6 Months After LASIK
Adverse Event Published Adverse Event Rates Adverse Event Rate (%) Reported by Manufacturers to FDA
Reported % Mean %
Dry Eyes 46.0 [8] ~22 ~20.6
9.0 [9]
35.3 [10]
12.5 [11]
20.8 [12]
27.0 [13]
4.0 [14] 5 years post LASIK
Night Vision Problems >6.19 [15] ~16 ~10.9
5.15 [16]
10.3 [17]
7.1 [18]
4.7 [19]
29.5 [20]
29.0 [21]
11.7 [22]
33.8 [23]
24.0 [24] 5 years post LASIK
Glare 12.0 [25] ~20 ~11.6
16.3 [26]
27.2 [27]
24.5 [28] 5 years post LASIK
Hallos 24.7 [29] ~19 ~14.1
30.0 [30]
3.0 [31] 5 years post LASIK

LASIK manufacturers and their collaborators emphasized “patient satisfaction” to divert FDA attention from continuing LASIK-patient complaints about glare, halos, dry eye and night driving problems. Reports by refractive surgeons that most patients are satisfied [32] with LASIK even as they report dry eyes and night vision impairment are suspect. Perhaps patients did not have these adverse events when they were asked if they were satisfied. Or, perhaps it was because post-LASIK complications surfaced months or years after LASIK surgery. Or the patient may report high satisfaction because of a need to justify to have LASIK in the first place.

LASIK manufacturers continue to falsely label their LASIK devices as having an adverse event rate of ≤1% (see manufacturers’ patient brochures [33]). To this moment they and their collaborators have been successfully engaged in a pattern of falsifying, misrepresenting, manipulating, and withholding safety and effectiveness data from FDA to make their LASIK devices appear safer than they are.

4. Manufacturers Distorted Effectiveness of LASIK Device

Table 3 shows manufacturers knew that about 43% of LASIK patients’ visual acuity could be improved by wearing spectacles 6–12 months after surgery. The manufacturers and their collaborators distorted this evidence.

Table 3 — Percent Patients That May Need Spectacles 6–12 Months After LASIK
Manufacturer FU (mos) Spectacles May be Needed
Kremer LASIK1232.7
Kremer LASIK1239.9
VISX Star S2654.1
Nidek EC–50001248.9
LADARVision967.3
LADARVision943.4
VISX Star S2, S3648.1
LaserSight1251.8
VISX Star S2,S3661.8
LADARVision 4000617.3
VISX Star S41227.9
Allegretto Wave1287.4
Allegretto Wave1267.5
LADARVision 4000622.9
VISX Star S4661.8
VISX Star WaveScan1227
VISX Star WaveScan1228.1
Allegretto Wave669.4
LADARVision 400099.4
LADARVision 4000 & 6000920.4
Alllegretto Wave640.3
Alllegretto Wave642.9
MEL-80633.4
Nidek EC-5000121.1
MEL-80692.7
VISX Star Wave1212.7
Sum = 1110.2
N = 26
Mean = 42.7

Initially, one of the FDA effectiveness measures used in the approval of excimer laser refractive surgery was the percent of post–LASIK patients that would not need spectacles or contact lenses (e.g., P930016S10 Patient Brochure). However, the manufacturers and their collaborators successfully lobbied FDA to eliminate labeling that would indicate the number of patients who might need corrective lenses post–LASIK, instead using percent uncorrected visual acuity less than or equal to 20/40. Candidates for LASIK are not informed that they have only about a 57% chance of getting rid of their spectacles or contact lenses but instead are told that there is a 95% chance that they will see better than 20/40. The manufacturers own data (Table 3) also showed that about 43% of patients’ vision could be improved with spectacles at 6 – 12 months after surgery.

Published evidence confirms a persistent double–digit adverse event rate for LASIK, and there has been no significant trend for improvement in night vision problems and dry eyes with changes in laser technology. The evidence from the PMAs show that the LASIK adverse event rate is at least twenty times the 1% rate acceptable to FDA and probably would be much worse if the manufacturers and their agents had not withheld and distorted the safety data. It is highly unlikely, if not impossible, that the FDA would have approved PMAs with a 20% adverse event rate and an effectiveness rate of 57%. Now let us turn to scientific evidence showing that LASIK devices transform healthy corneas into unhealthy ones (Section B).

Initially, one of the FDA effectiveness measures used in the approval of excimer laser refractive surgery was the percent of post–LASIK patients that would not need spectacles or contact lenses (e.g., P930016S10 Patient Brochure). However, the manufacturers and their collaborators successfully lobbied FDA to eliminate labeling that would indicate the number of patients who might need corrective lenses post–LASIK, instead using percent uncorrected visual acuity less than or equal to 20/40. Candidates for LASIK are not informed that they have only about a 57% chance of getting rid of their spectacles or contact lenses but instead are told that there is a 95% chance that they will see better than 20/40. The manufacturers own data (Table 3) also showed that about 43% of patients’ vision could be improved with spectacles at 6 – 12 months after surgery.

Published evidence confirms a persistent double–digit adverse event rate for LASIK, and there has been no significant trend for improvement in night vision problems and dry eyes with changes in laser technology. The evidence from the PMAs show that the LASIK adverse event rate is at least twenty times the 1% rate acceptable to FDA and probably would be much worse if the manufacturers and their agents had not withheld and distorted the safety data. It is highly unlikely, if not impossible, that the FDA would have approved PMAs with a 20% adverse event rate and an effectiveness rate of 57%. Now let us turn to scientific evidence showing that LASIK devices transform healthy corneas into unhealthy ones (Section B).

B. LASIK Creates Sick Corneas From Normal Ones

Published scientific reports demonstrate that LASIK devices make normal corneas sick: the corneal interface never heals completely; is permanently weakened and vulnerable to thinning and bulging (keratectasia), which may require hard contact lenses and corneal transplant. After LASIK a drier often painful and distorted corneal surface compromises night driving.

1. LASIK flap never completely heals

LASIK patients have permanently weak and sick corneas. It is shown that all post–mortem LASIK corneas examined have “permanent pathological changes” [34]. Since the LASIK flap never heals completely [35] it is at a lifetime risk of dislocation. This fragile flap is vulnerable to traumatic eye injury and infection for the remainder of the patient’s life, and numerous reports of dislodged and amputated flaps exist in the literature, [36] even after minor trauma [37]. Diffuse inflammation under the flap (called diffuse lamellar keratitis) is reported to occur as late as 12 years postoperatively [38]. The average incidence of this surgically induced and sight–threatening inflammation is as high with the newer technology of femtosecond laser flap maker as it is with the older mechanical microkeratome [39].

2. LASIK permanently weakens the cornea

The post–LASIK cornea has a mechanical strength of only ~2% of normal cornea: “Corneal stromal LASIK wounds were found to heal weaker than normal because these structures were not regenerated during the healing response. Moreover, the central and paracentral stromal LASIK wounds were found to heal by producing a hypocellular primitive stromal scar that is very weak in tensile strength, averaging 2.4% of normal, and displays no evidence of remodeling over time in specimens out to 6.5 years after surgery.” [40]

3. LASIK severs corneal nerves, causing neuropathic dry eyes

The nerves destroyed by LASIK devices are needed for tear production. These nerves never fully recover, often leading to permanent dry eye disease [41]. Post–LASIK dry eye is a neuropathic epitheliopathy, [42] a medical device induced epidemic. Dry eye is the most common complication of LASIK surgery [43], [44]. Figure 8 shows how LASIK causes neuropathic dry eye [45].

Patients are not adequately informed of the seriousness and chronic nature of post–LASIK dry eye disease. Moderate chronic dry eye produces a pain level comparable to moderate angina to those who experience it [46]. Six months after LASIK patients with dry eyes (48%) experience soreness of the eye to the touch (6.7%), sharp pains (8.0%), and eyelid sticking to the eyeball (5.6%) [47].

LASIK induces dry eye in 46% of cases performed with mechanical microkeratomes and 9% with the femtosecond laser flap–maker; no subjects had dry eye symptoms preoperatively [48]. Corneal nerves severed and ablated by LASIK never return to their pre–surgical densities and patterns [49]. The LASIKinduced incidence of dry eyes at six months is reported at 12.5% in eyes with nasal hinges and 35.3% in eyes with superior–hinges [50].

Dry eyes can occur due to contact lens wear but this dry eye is not due to neuropathy. Moreover, removing the contact lenses and treatment with eye drops, are likely to restore the cornea surface to normality. In contrast, LASIK severs corneal nerves in otherwise healthy eyes causing corneal dryness that is essentially permanent since these nerves never completely regenerate.

LASIK Industry Graph Showing False Data

Figure 8 – LASIK Cuts Corneal Nerves, Causing a Dry and Irritated Cornea

Based mostly on: Abelson MB. A Different Animal: Post–LASIK Dry Eye. Rev. Ophthalmology, Vol. No: 9:08 Issue: 8/15/02 (The statement that “50% LASIK Patients Suffer for More Than Six Months” is based on published data cited in Table 2.)

4. LASIK Devices Induce Progressive Pathology in the Cornea

LASIK devices do more damage than cutting corneal nerves; they also cause progressive loss of important corneal cells called keratocytes. LASIK devices change the biomechanical, anatomical, and molecular dynamics of the eye [51]. The cornea is deformed with a rapid rise and fall of intraocular pressure; the flap is cut and brushed back onto a hinge. Then the laser craters the stroma and the flap floated to cover the void.

One of the most striking long–term pathological changes in the post–LASIK cornea is the 5–year progressive decline in the density of corneal stromal keratocytes [52]. Figure 9 shows this decline and Table 4 shows the annual rate of keratocyte loss. Keratocyte density declines in LASIK–induced thinning and bulging of the cornea (keratectasia) but NOT in keratoconic corneas [53]. The density of keratocytes is probably related to corneal stiffness [54], however, it not yet known if it is linked to keratectasia or some other disease process.

LASIK Industry Graph Showing False Data

Figure 9 – LASIK Causes Progressive Loss of Keratocytes

From: Erie JC, McLaren JW, Hodge DO, Bourne WM. Long–term corneal keratoctye deficits after photorefractive keratectomy and laser in situ keratomileusis. Trans Am Ophthalmol Soc. 2005;103:56–66; discussion 67–8. 39: “FIGURE 5 Keratocyte density before and after LASIK. In the anterior and posterior stromal flap and the anterior retroablation zone (RAZ), keratocyte density was decreased at all post–LASIK visits from density before LASIK. Cell densities in all remaining stromal layers were first decreased at 5 years after LASIK. *P < .005 and P < .05, when compared with densities before LASIK.”
Table 4. CHANGE IN KERATOCYTE DENSITY BETWEEN 6 MONTHS AND 5 YEARS AFTER LASIK [55]
Stromal Layer Rate of Change (% Per Year)
Anterior flap –4.3 ± 3.2
Posterior flap –7.2 ± 4.3
Anterior RAZ (0 to 50 μm) –8.4 ± 3.7
Posterior RAZ (51 to 100 μm) –2.6 ± 4.1
Posterior 66% to 90% –3.5 ± 3.4
Posterior 91% to 100% –3.1 ± 2.2

5. LASIK Causes Keratectasia, a Sight-Threatening Disorder

The post–LASIK cornea may become thin and bulge weeks, months, or years later to become the potentially blinding condition of keratectasia [56] Table 5 summarizes some of the reports of keratectasia [57] The absence of keratectasia findings in LASIK is likely due to the failure of long–term follow up [58] an interpretation that is consistent with the failure to report adverse events and to followup on patients for an extended period of time. Patients may also choose to see a surgeon or eye care practitioner other than the one who performed LASIK and caused the problem they are experiencing.

In a personal communication Dr. Edward Boshnick says that he has at least 75 patients with LASIKinduced keratectasia [59] strongly suggesting a much higher percentage of LASIK–induced bulging of the cornea than is reported by refractive surgery businesses (user facilities) in the professional journals they control. A worst–case approach would be to select 0.9% as the keratectasia rate. It seems likely that there is a large degree of under reporting of keratectasia so that it is likely that keratectasia rate is at least 0.66%

Table 5 — Incidence of LASIK Induced Corneal Bulging

Binder PS. Analysis of ectasia after laser in situkeratomileusis: Risk factors

Table 1. Reported incidence of post-LASIK ectasia.
Source Number (%)
Reinstein3,* 6/5212 (0.12)
Pallakaris4 19/2873 (0.66)
Rad5 (0.2)
Condon6 3/140 (0.8)
Current 3/9283 (0.01)
Kansky (0.9)
Sergey 13/23990 (0.05)
Oliviera 6/2500 (0.24)
Stulting§ R1:5000
ESCRS registry of ectasia cases (9/2006) 72
*Projection
Myopic errors
Data presented at the XXIV Congress of the European Society of Cataract & Refractive Surgeons, London, England, September 2006
§Data presented at the annual meeting of the American Academy of Ophthalmology, Las Vegas, Nevada, USA, November 2006; projection based on literature reports

6. LASIK Induces Corneal Distortions

In the attempt to correct defocus (sphere) and astigmatism (cylinder) LASIK devices induce distortions that degrade vision. LASIK devices make corneas more pancake–like [60], often de–centered, warped, chaotic, and rough with stromal microfolds [61].

Several issues must be resolved in order to prevent double–digit rate of the adverse effects of blur, haloes, glare and night vision losses [62], [63]. These unresolved safety issues include, but are not limited to, laser beam characteristics, alignment issues, corneal tissue thickness, spatial ablation efficiency, [64] large variability in flap thickness, tissue biomechanics and healing response [65] on the alteration of the intended surface structure prescribed for a given treatment [66].

Dr. Leo Maguire forewarned of the public health threat of LASIK in an editorial published in the March, 1994 edition of American Journal of Ophthalmology: [67]

“I hope the reader will now understand how a patient may have clinically acceptable 20/20 visual acuity in the daytime and still suffer from clinically dangerous visual aberration at night if that patient’s visual system must cope with an altered refractive error, increased glare, poorer contrast discrimination, and preferentially degraded peripheral vision. People die at night in motor vehicle accidents four times as frequently as they do during the day, and these figures are adjusted for miles driven. Night driving presents a hazardous visual experience to adults without aberrations. When we discuss aberration at night we are considering a possible morbid effect of refractive surgery.”

In a normal eye LASIK can only increase corneal aberrations. LASIK–induced aberrations are significant in magnitude, adverse consequences, and frequency. Even the newer wavefront–guided LASIK, that is, LASIK guided by aberration measurements of the client’s healthy cornea, increases higher order aberrations with commensurate losses in contrast sensitivity in myopic eyes greater than or equal to –6D [68]. LASIK increases both corneal and total aberrations with changes in the anterior and posterior corneal surfaces contributing to the rise in higher order aberrations [69], [70]. LASIK may correct distortions such as defocus but it induces other distortions. Figure 10 shows the LASIK–induced increase in higher order aberrations. [71]

According to published studies, higher order distortions induced by LASIK are significantly correlated with loss of quality of vision, [72] such as loss of contrast sensitivity, [73] and increases in halos and night vision problems [74], [75]. In addition, LASIK–induced higher order aberrations are more troublesome in binocular than in monocular viewing [76]. Moreover, binocular vision worsens during post–LASIK recovery because the interocular differences in higher order aberrations increases as each cornea re–models itself to the specific pattern of injuries introduced into each eye.

LASIK Industry Graph Showing False Data

Figure 10 – LASIK–Induced Distortions

From: Moreno–Barriuso E, Lloves JM, Marcos S, et al. Ocular aberrations before and after myopic corneal refractive surgery: LASIKinduced changes measured with laser ray tracing. Invest Ophthalmol Vis Sci 2001; 42:1396–1403: “FIGURE 8. Average MTF (radial profile) before and after LASIK, computed from the wave aberration, and for a 6.5-­‐mm pupil diameter and 543 nm. The solid lines are the average across 22 eyes, and the bars are the SE for selected frequencies. The diffraction-­‐limited MTF is included for comparison purposes.”

Some LASIK manufacturers and allied clinics report waveguided–LASIK devices do not increase higher order aberrations [77] or cause fewer halos and night vision problems than conventional LASIK devices. [78], [79], [80] Still others report waveguided–LASIK does increase higher order aberrations [81] or increase aberrations more for one LASIK device than another [82]. Other studies report no significant improvement of waveguide–LASIK compared to conventional LASIK. [83].

7. Persistent post–LASIK Loss of Contrast Sensitivity in Dim Light

There is considerable evidence that LASIK induces corneal aberrations that are linked to losses in contrast sensitivity and critical losses of vision [84]. Most of the decrease in post–LASIK contrast sensitivity found can be explained and computed directly from the physical measurement of the wave aberration [85]. LASIK increases higher order aberrations and decreases contrast sensitivity at 6 and 12 months. There are no data after 12 months but it can be assumed from the high percentage of contrast sensitivity loss and night vision disturbances that have been reported remain as long as the cornea is unstable, which appears to be many years.

LASIK manufacturers and their collaborators successfully lobbied FDA to use a 6 mm pupil diameter for measuring safety and effectiveness instead of a larger one. Also, they successfully lobbied FDA not to require LASIK manufacturers to measure contrast sensitivity in dim light before and after LASIK [86]. Since the induction of visual aberrations are directly related to pupil size, this practice effectively “clip off” aberrations outside the 6 mm central zone and ignore the aberrations that patients see in dim light through a large pupil. The consequences of these decisions are seen below.

Table 6 shows contrast sensitivity losses for the VISX LASIK device. At 6 months LASIK reduces low contrast visual acuity one to two diopters for 20.2% of the subjects while 2.2% of patients lose more than 2 diopters. Also, predictably contrast sensitivity losses in dim light are worse (9.1%) than losses in bright light (3.8%). Contrast sensitivity in dim light with a glare source is worse (16.4%) than in dim light without glare (14.2%) which in turn is worse than in bright light without glare (6.3%). These losses in contrast sensitivity persist 12 months after LASIK.

LASIK induces dim light contrast sensitivity losses by light scatter (haze) at high spatial frequencies and by defocus (optical aberrations) at medium and high spatial frequencies [87]. Also, LASIK causes loss of sensitivity in the midperipheral visual field correlated with refractive error, flap thickness, and optical zone diameter [88].

Table 6 – Persistent Loss of Contrast Detection after LASIK
Type of Loss 6 Months (%loss) 12 Months
Low contrast visual acuity Mean = 20.2  
1.0-2.0D 20.9 [cit10], 11.8 [cit11], 26.2 [cit12], 21.8 [cit13] No Data
>2D 2.2c No Data
Bright light contrast sensitivity Mean = 3.8  
  0.7 [cit14], 1.7 [cit15], 7.5f, 5.5 [cit16] No Data
Dim light contrast sensitivity Mean = 9.1 No data
  5.8b, 7.3d, 12.9f, 10.3g  
Contrast Sensitivity Mean = 6.3  
Bright light without glare 4.5 [cit17], 3.8 [cit18], 10.7 [cit19] 1.6j, 14.0k,
  Mean = 14.2 4.8j, 15.9k,
Dim light without glare 21.8i, 5.0j, 15.7k,  
  Mean = 16.4 4.8j, 13.1k,
Dim light with glare 27.1i, 5.0j, 22.5k,  
>2 Line Decrease in CS [cit20]    
Bright without glare 1.0 No data
Dim without glare 8.0 No data
Dim with glare 9.0 No data

8. LASIK is Unstable and Regresses

Multiple studies have determined that the effects of LASIK are unstable and regress. Seven years after LASIK fifty–five percent are unhappy with their vision and the number of eyes that lost 2 or more lines of visual acuity has doubled [89]. Another study found similar results at 8 years with only 39% of highly myopic [cit21] eyes with a visual acuity of 20/20 uncorrected, along with a significant increase in higher order aberrations, and decrease in contrast sensitivity; deterioration in vision occurred even after wavefront–guided LASIK [90]. Similar vision deterioration over time has been found after corneal surgery with other LASIK devices [91], [92].

9. LASIK Creates the Need for Additional Eye Care

A catalogue of the additional medical care that LASIK patients require is beyond the scope of this petition. However, this care is considerable, costly, and often accompanied by additional risk. LASIK patients often need treatment for LASIK–induced adverse events including but not limited to dry eyes, night vision impairment, diffuse lamellar keratitis, and keratectasia. Two additional problems are particularly thorny.

a. LASIK Increases Risk of Undiagnosed Glaucoma

Having LASIK increases the lifetime risk of undiagnosed glaucoma because the post–LASIK cornea produces falsely low intraocular pressure (IOP) readings. IOP measurements are performed during routine eye exams to screen for glaucoma. Therefore, vision–threatening glaucoma may go undiagnosed and untreated in patients who have had LASIK surgery [93]. Glaucoma is a leading cause of blindness.

b. LASIK Increases risk of Poor Outcome Following Cataract Surgery

Also, because LASIK devices change corneal shape, the risk of a poor outcome from cataract surgery is increased [94]. Most people who have LASIK will require cataract surgery later in life and the surgeon’s measurements of post–LASIK corneas to calculate the appropriate intraocular lens (IOL) power will likely be inaccurate.

10. Newer LASIK Devices Cause the Same Permanent Corneal Damage as Older Models.

Newer technologies have not resolved problems inherent in the LASIK procedure, such as induction of aberrations that impair night vision and nerve damage that causes post–LASIK dry eye [95]. In fact, studies show that wavefront–guided and wavefront–optimized LASIK actually increase, not decrease, higher order aberrations, reducing visual quality in previously untreated eyes [96]. This study demonstrates that wavefront guided LASIK induces a 1.9 fold increase in total aberrations at 6 months, a 5–fold increase in vertical distortions and a large increase in spherical aberrations [97]. A review of the literature on wavefront–guided LASIK concludes that evidence does not support claims that wavefront out performs conventional LASIK [98]. Femtosecond laser flap creation does not reduce the incidence of most complications [99]. Furthermore, femtosecond–created laser flaps are more difficult to lift than flaps created with a blade, which may result in a higher incidence of torn flaps. The femtosecond laser keratome currently requires longer suction on the eye than blade microkeratomes to create the LASIK flap. The incidence of suction ring–induced posterior vitreous detachment with blade microkeratomes is high at 13% overall, and 24% for patients with high myopia in one study [100]. A search of peer–reviewed literature reveals problems associated with the femtosecond laser such as slipped flaps, interface inflammation, flap folds, infectious keratitis, corneal stromal inflammation, delayed wound healing, macular hemorrhage, and gas bubbles in the anterior chamber after surgery [101].


Citations

[cit6]Table 1
[cit7]The source documents for these data are identified in Table 1A, Appendix.
[cit8]I will submit CONFIDENTIAL information on these matters to FDA’s Office of Criminal Investigation.
[cit9]See Table 3A, Appendix
[cit10]Table 16 – 970043S10b
[cit11]Table 19 – P970043S15b
[cit12]Table 26 – S20b
[cit13]Table 26 – S22b
[cit14]Table 19 – P970043S10b
[cit15]Table 21 – P970043S15b
[cit16]Table 28 – S22b
[cit17]Table 11 – S17b
[cit18]Table 11 – S20b
[cit19]Table 22 – S21b
[cit20]Table 36 – S25b
[cit21]Highly myopic defined as equal to or greater than –6 D. Table 36 – S25b

Footnotes

[1]http://www.agingeye.net/lasik/lasik.php
[2]http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061270.htm
[3]http://www.bausch.com/en_US/consumer/surgical/consider.aspx;
[4]CDRH, FDA October 10, 1996. Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers
[5]http://www.lasiknewswire.com/2009/04/fda-update-on-lasik.html
[6]FDA, OPHTHALMIC DEVICES PANEL Eighty–Seventh Meeting, Tuesday, January 14, 1997. Comments by Marc Odrich, MD (VISX Inc) pp. 89–92.
[7]Confidential information to be submitted to FDA’s Office of Criminal Investigation
[8]Salomao MQ, Ambrosio R Jr, Wilson SE. Dry eye associated with laser in situ keratomileusis: mechanical microkeratome versus femtosecond laser. J Cataract Refract Surg 2009; 35:1756–1760
[9]Schmidt GW, Yoon M, McGwin G, Lee PP, McLeod SD. Evaluation of the Relationship Between Ablation Diameter, Pupil Size, and Visual Function With Vision–Specific Quality–of–Life Measures After Laser In Situ Keratomileusis. Arch Ophthalmol. 2007;125(8):1037–1042
[10]De Paiva CS, Chen Z, Koch DD, Hamill MB, Manuel FK, Hassan SS, Wilhelmus KR, Pflugfelder SC. The incidence and risk factors for developing dry eye after myopic LASIK. Am J Ophthalmol. 2006 Mar; 141(3):438–45.
[11]Salomao MQ, Ambrosio R Jr, Wilson SE. Dry eye associated with laser in situ keratomileusis: mechanical microkeratome versus femtosecond laser. J Cataract Refract Surg 2009; 35:1756–1760.
[12]Schmidt GW, Yoon M, McGwin G, Lee PP, McLeod SD. Evaluation of the Relationship Between Ablation Diameter, Pupil Size, and Visual Function With Vision–Specific Quality–of–Life Measures After Laser In Situ Keratomileusis. Arch Ophthalmol. 2007;125(8):1037–1042 13 Miller AE, McCulley JP, Bowman RW, Cavanagh HD, Wang XH. Patient satisfaction after LASIK for myopia. CLAO J 2001;27:84–8.
[13]Miller AE, McCulley JP, Bowman RW, Cavanagh HD, Wang XH. Patient satisfaction after LASIK for myopia. CLAO J 2001;27:84–8.
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[16]Schmidt GW, Yoon M, McGwin G, Lee PP, McLeod SD. Evaluation of the Relationship Between Ablation Diameter, Pupil Size, and Visual Function With Vision–Specific Quality–of–Life Measures After Laser In Situ Keratomileusis. Arch Ophthalmol. 2007;125(8):1037–1042
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